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Short abstract:

Analysis of the deficits in reasonableness experienced when approving or refusing exceptional access to drugs for individual patients in Quebec. Here, an epistemic concept of democratic reasonableness is used as a heuristic to reveal issues of fairness at the systemic/programmatic level.

Long abstract:

This communication will present an analysis of the deficits in reasonableness experienced when approving or refusing exceptional access to drugs for individual patients in Quebec, under a specific regulatory statute called "particular medical necessity" (PMN). As elsewhere, Quebec is under pressure as drug therapies target ever more specific conditions while marketed at significant costs.

Here, the implications of this pressure are examined at a specific locus, as the NMP mechanism has become a vehicle by which the traditional logic of regulating access through indications gives way to a logic of judging access on a case-by-case basis. Together, local NMP committees bear the weight of decisions with major ethical and societal implications.

In examining the results of research carried out with NMP committees, we will use an epistemic concept of democratic reasonableness, which locates the anchoring of reasonableness within the intellectual practices that enable NMP committees to appreciate the desirability of responding to an access request relative to other requests. Hence, the distinctiveness of this normative approach is as a heuristic to reveal issues at the systemic/programmatic level. Our analysis will show how the difficulties experienced by NMP committees in making decisions they deem fair and reasonable go beyond classic issues of evaluation methodology, as they also point to structural origins (e.g., incoherent epistemic basis for defining the ‘particular’, proposed drug uses without an institutionalized path to access, etc.). This analysis will contribute to the international discussion on more integrated and reasonable access to drugs within the current pharmaceutical paradigm shift.